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Pharmaceutical Process Scale-Up

Marcel Dekker, York BaselTMPharmaceuticalProcess Scale-Upedited byMichael LevinMetropolitan Computing CorporationEast Hanover, New JerseyCopyright 2001 by Marcel Dekker, Inc. All Rights : 0-8247-0625-0 This book is printed on acid-free Dekker, Madison Avenue, New York, NY 10016tel: 212-696-9000; fax: 212-685-4540 Eastern Hemisphere DistributionMarcel Dekker AGHutgasse 4, Postfach 812, CH-4001 Basel, Switzerlandtel: 41-61-261-8482; fax: 41-61-261-8896 World Wide publisher offers discounts on this book when ordered in bulk quantities. For more in-formation, write to Special Sales/Professional Marketing at the headquarters 2002 by Marcel Dekker, Inc. All Rights this book nor any part may be reproduced or transmitted in any form or by anymeans, electronic or mechanical, including photocopying, microfilming, and recording, orby any information storage and retrieval system, without permission in writing from printing (last digit):10987654321 PRINTED IN THE UNITED STATES OF AMERICADRUGS AND THE Pharmaceutical SCIENCESE xecutive EditorJames SwarbrickPharmaceuTech, , North CarolinaAdvisory BoardLarry L.

33. Pharmacokinetics: Regulatory · Industrial · Academic Perspectives, edited by Peter G. Welling and Francis L. S. Tse 34. ... Biodegradable Polymers as Drug Delivery Systems, edited by Mark Chasin and Robert Langer 46. ... 94. Pharmaceutical Excipients: Characterization by IR, Raman, and NMR Spectroscopy, David E. Bugay and W. Paul Findlay 95.

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1 Marcel Dekker, York BaselTMPharmaceuticalProcess Scale-Upedited byMichael LevinMetropolitan Computing CorporationEast Hanover, New JerseyCopyright 2001 by Marcel Dekker, Inc. All Rights : 0-8247-0625-0 This book is printed on acid-free Dekker, Madison Avenue, New York, NY 10016tel: 212-696-9000; fax: 212-685-4540 Eastern Hemisphere DistributionMarcel Dekker AGHutgasse 4, Postfach 812, CH-4001 Basel, Switzerlandtel: 41-61-261-8482; fax: 41-61-261-8896 World Wide publisher offers discounts on this book when ordered in bulk quantities. For more in-formation, write to Special Sales/Professional Marketing at the headquarters 2002 by Marcel Dekker, Inc. All Rights this book nor any part may be reproduced or transmitted in any form or by anymeans, electronic or mechanical, including photocopying, microfilming, and recording, orby any information storage and retrieval system, without permission in writing from printing (last digit):10987654321 PRINTED IN THE UNITED STATES OF AMERICADRUGS AND THE Pharmaceutical SCIENCESE xecutive EditorJames SwarbrickPharmaceuTech, , North CarolinaAdvisory BoardLarry L.

2 AugsburgerUniversity of MarylandBaltimore, MarylandDavid E. NicholsPurdue UniversityWest Lafayette, IndianaDouwe D. BreimerGorlaeus LaboratoriesLeiden, The NetherlandsStephen G. SchulmanUniversity of FloridaGainesville, FloridaTrevor M. JonesThe Association of theBritish Pharmaceutical IndustryLondon, United KingdomJerome P. SkellyAlexandria, VirginiaHans E. JungingerLeiden/Amsterdam Centerfor Drug ResearchLeiden, The NetherlandsFelix TheeuwesAlza CorporationPalo Alto, CaliforniaVincent H. L. LeeUniversity of Southern CaliforniaLos Angeles, CaliforniaGeoffrey T. TuckerUniversity of SheffieldRoyal Hallamshire HospitalSheffield, United KingdomPeter G. WellingInstitut de Recherche JouveinalFresnes, FranceDRUGS AND THE Pharmaceutical SCIENCESA Series of Textbooks and Monographs1. Pharmacokinetics,Milo Gibaldi and Donald Perrier2.

3 Good Manufacturing Practices for Pharmaceuticals: A Plan for TotalQuality Control,Sidney H. Willig, Murray M. Tuckerman, and WilliamS. Hitchings IV3. Microencapsulation,edited by J. R. Nixon4. Drug Metabolism: Chemical and Biochemical Aspects,Bernard Testaand Peter Jenner5. New Drugs: Discovery and Development,edited by Alan A. Rubin6. Sustained and Controlled Release Drug Delivery Systems,edited byJoseph R. Robinson7. Modern Pharmaceutics,edited by Gilbert S. Banker and ChristopherT. Rhodes8. Prescription Drugs in Short Supply: Case Histories,Michael Activated Charcoal: Antidotal and Other Medical Uses,David Concepts in Drug Metabolism (in two parts),edited by Peter Jennerand Bernard Testa11. Pharmaceutical Analysis: Modern Methods (in two parts),edited byJames W. Munson12. Techniques of Solubilization of Drugs,edited by Samuel H.

4 Yalkowsky13. Orphan Drugs,edited by Fred E. Karch14. Novel Drug Delivery Systems: Fundamentals, Developmental Con-cepts, Biomedical Assessments,Yie W. Chien15. Pharmacokinetics: SecondEdition, Revised and Expanded,MiloGibaldi and Donald Perrier16. Good Manufacturing Practices for Pharmaceuticals: A Plan for TotalQuality Control, Second Edition, Revised and Expanded,Sidney , Murray M. Tuckerman, and William S. Hitchings IV17. Formulation of Veterinary Dosage Forms,edited by Jack Blodinger18. Dermatological Formulations: Percutaneous Absorption,Brian The Clinical Research Process in the Pharmaceutical Industry,editedby Gary M. Matoren20. Microencapsulation and Related Drug Processes,Patrick B. Deasy21. Drugs and Nutrients: The Interactive Effects,edited by Daphne and T. Colin Campbell22. Biotechnology of industrial Antibiotics,Erick J.

5 Vandamme23. Pharmaceutical Process Validation,edited by Bernard T. Loftus andRobert A. Nash24. Anticancer and Interferon Agents: Synthesis and Properties,edited byRaphael M. Ottenbrite and George B. Butler25. Pharmaceutical Statistics: Practical and Clinical Applications,SanfordBolton26. Drug Dynamics for Analytical, Clinical, and Biological Chemists,Benjamin J. Gudzinowicz, Burrows T. Younkin, Jr., and Michael Modern Analysis of Antibiotics,edited by Adjoran Aszalos28. Solubility and Related Properties,Kenneth C. James29. Controlled Drug Delivery: Fundamentals and Applications, SecondEdition, Revised and Expanded,edited by Joseph R. Robinson andVincent H. Lee30. New Drug Approval Process : Clinical and Regulatory Management,edited by Richard A. Guarino31. Transdermal Controlled Systemic Medications,edited by Yie Drug Delivery Devices: Fundamentals and Applications,edited byPraveen Tyle33.

6 Pharmacokinetics: Regulatory industrial Academic Perspectives,edited by Peter G. Welling and Francis L. S. Tse34. Clinical Drug Trials and Tribulations,edited by Allen E. Cato35. Transdermal Drug Delivery: Developmental Issues and Research Ini-tiatives,edited by Jonathan Hadgraft and Richard H. Guy36. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms,edited by James W. McGinity37. Pharmaceutical Pelletization Technology,edited by Isaac Ghebre-Sellassie38. Good Laboratory Practice Regulations,edited by Allen F. Hirsch39. Nasal Systemic Drug Delivery,Yie W. Chien, Kenneth S. E. Su, andShyi-Feu Chang40. Modern Pharmaceutics: Second Edition, Revised and Expanded,edited by Gilbert S. Banker and Christopher T. Rhodes41. Specialized Drug Delivery Systems: Manufacturing and ProductionTechnology,edited by Praveen Tyle42.

7 Topical Drug Delivery Formulations,edited by David W. Osborne andAnton H. Amann43. Drug Stability: Principles and Practices,Jens T. Carstensen44. Pharmaceutical Statistics: Practical and Clinical Applications, SecondEdition, Revised and Expanded,Sanford Bolton45. Biodegradable Polymers as Drug Delivery Systems,edited by MarkChasin and Robert Langer46. Preclinical Drug Disposition: A Laboratory Handbook,Francis L. and James J. Jaffe47. HPLC in the Pharmaceutical Industry,edited by Godwin W. Fong andStanley K. Lam48. Pharmaceutical Bioequivalence,edited by Peter G. Welling, Francis Tse, and Shrikant V. Dinghe49. Pharmaceutical Dissolution Testing,Umesh V. Banakar50. Novel Drug Delivery Systems: Second Edition, Revised andExpanded,Yie W. Chien51. Managing the Clinical Drug Development Process ,David M. Coc-chetto and Ronald V.

8 Nardi52. Good Manufacturing Practices for Pharmaceuticals: A Plan for TotalQuality Control, Third Edition,edited by Sidney H. Willig and JamesR. Stoker53. Prodrugs: Topical and Ocular Drug Delivery,edited by Kenneth Pharmaceutical Inhalation Aerosol Technology,edited by Anthony Radiopharmaceuticals: Chemistry and Pharmacology,edited byAdrian D. Nunn56. New Drug Approval Process : Second Edition, Revised and Expanded,edited by Richard A. Guarino57. Pharmaceutical Process Validation: Second Edition, Revised and Ex-panded,edited by Ira R. Berry and Robert A. Nash58. Ophthalmic Drug Delivery Systems,edited by Ashim K. Mitra59. Pharmaceutical Skin Penetration Enhancement,edited by Kenneth and Jonathan Hadgraft60. Colonic Drug Absorption and Metabolism,edited by Peter R. Bieck61. Pharmaceutical Particulate Carriers: Therapeutic Applications,editedby Alain Rolland62.

9 Drug Permeation Enhancement: Theory and Applications,edited byDean S. Hsieh63. Glycopeptide Antibiotics,edited by Ramakrishnan Nagarajan64. Achieving Sterility in Medical and Pharmaceutical Products,Nigel Multiparticulate Oral Drug Delivery,edited by Isaac Ghebre-Sellassie66. Colloidal Drug Delivery Systems,edited by J rg Kreuter67. Pharmacokinetics: Regulatory industrial Academic Perspectives,Second Edition,edited by Peter G. Welling and Francis L. S. Tse68. Drug Stability: Principles and Practices, Second Edition, Revised andExpanded,Jens T. Carstensen69. Good Laboratory Practice Regulations: Second Edition, Revised andExpanded,edited by Sandy Weinberg70. Physical characterization of Pharmaceutical Solids,edited by HarryG. Brittain71. Pharmaceutical Powder Compaction Technology,edited by G ran Al-derborn and Christer Nystr m72.

10 Modern Pharmaceutics: Third Edition, Revised and Expanded,editedby Gilbert S. Banker and Christopher T. Rhodes73. Microencapsulation: Methodsand industrial Applications,edited bySimon Benita74. Oral Mucosal Drug Delivery,edited by Michael J. Rathbone75. Clinical Research in Pharmaceutical Development,edited by BarryBleidt and Michael Montagne76. The Drug Development Process : Increasing Efficiency and Cost Ef-fectiveness,edited by Peter G. Welling, Louis Lasagna, and UmeshV. Banakar77. Microparticulate Systems for the Delivery of Proteins and Vaccines,edited by Smadar Cohen and Howard Bernstein78. Good Manufacturing Practices for Pharmaceuticals: A Plan for TotalQuality Control, Fourth Edition, Revised and Expanded,Sidney and James R. Stoker79. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms:Second Edition, Revised and Expanded,edited by James Pharmaceutical Statistics: Practical and Clinical Applications, ThirdEdition,Sanford Bolton81.